Harmony Biosciences sets terms on $100M IPO; FDA accepts a Protalix BLA for review
Paragon portfolio company Harmony Biosciences announced its IPO terms on Tuesday, which set a range of $20 and $23 a share.
The Pennsylvania-based company, which initially filed for a $100 million IPO weeks ago, plans on offering 4.7 million shares. It seeks to raise roughly $100 million, which will fund the clinical advancement of its drug pitolisant.
Jeff Aronin — who serves as chairman of the Harmony board — stirred up controversy several years ago when he directed an old steroid he picked up cheap to Duchenne MD patients for $89,000. But that isn’t the only drama on the executive board — former CEO Bob Repella pled guilty to mail fraud in May in a college admissions scandal.
Harmony acquired pitolisant from Bioprojet in France, and now sells it as Wakix to treat excessive daytime sleepiness for adults with narcolepsy. Plans are in place for other indications, including pediatric EDS and cataplexy, according to the S-1. It’s expected to enter a Phase III clinical trial in pediatric patients later this year, and resubmit a response to the FDA for an adult cataplexy indication. — Nicole DeFeudis
FDA accepts Protalix license application for drug that treats Fabry disease
An Israeli biotech that develops therapies from plant-based proteins got some good news from US regulators Tuesday.
Protalix BioTherapeutics announced that the FDA has accepted the company’s biologics license application for pegunigalsidase alfa (or PRX-102) and granted the candidate priority review for the treatment of adults with Fabry disease. The PDUFA date set by regulators is January 27, 2021.
The biotech has been developing PRX-102, a plant cell culture-expressed and chemically modified version of the alpha-Galactosidase-A enzyme, with a subsidiary of Italian pharma Chiesi. In clinical studies, PRX-102 has been observed to have a circulatory half-life of approximately 80 hours.
Fabry disease is a rare genetic disorder that prevents the body from making the alpha-Galactosidase-A enzyme, resulting in abnormal deposits of fatty substances in blood vessel walls. The ultimate consequences of these deposits can range from pain and impaired peripheral sensation to kidney and heart failure. — Max Gelman